Perioperative docetaxel, oxaliplatin, and 5-fluorouracil/leucovorin treatment should be a new standard of care for patients with operable adenocarcinoma of the stomach or gastroesophageal junction, say the FLOT4-AIO trial investigators.

In the phase III trial – which investigated the addition of irinotecan to fluorouracil plus leucovorin – the incidence of any-grade or grade 3 or 4 alopecia, stomatitis, diarrhea, nausea, leukopenia, neutropenia, and anemia was significantly higher among female participants (n=1318; 44.3%) than their male counterparts (n=1656; 55.7%) when the study arms were pooled.

Participants were randomly assigned to receive mFOLFIRINOX – comprising fluorouracil 2.4 mg/m 2 over 46 hours, oxaliplatin 85 mg/m 2 , leucovorin 400 mg/m 2 plus irinotecan 150–180 mg/m 2 – every 2 weeks for up to 12 cycles, or gemcitabine at a dose of 1000 mg/m 2 every 3 or 4 weeks for a maximum of six cycles.

All patients were given the Children’s Oncology Group augmented Berlin-Frankfurt-Munster (aBFM) chemotherapy regimen and were randomly assigned to receive an escalating dose of methotrexate alone or high-dose methotrexate given alongside leucovorin rescue.

Overall, 136 (70.5%) of 193 patients (mean age 64 years, 49.7% women) with borderline resectable or locally advanced pancreatic cancer underwent resection following neoadjuvant therapy, typically with fluorouracil, irinotecan, oxaliplatin, leucovorin, and folic acid (64.2%).

The idea behind the IDEA (International Duration Evaluation of Adjuvant Therapy) collaboration was to pool together data from six clinical trials to establish the noninferiority of 3 months of FOLFOX (fluorouracil, leucovorin and oxaliplatin) or CAPOX (capecitabine plus oxaliplatin) adjuvant chemotherapy versus a 6-month regimen.

The patients were randomly assigned to receive treatment with mXELIRI (capecitabine plus irinotecan; n=326) or FOLFIRI (leucovorin, fluorouracil, and irinotecan; n=324), with approximately 83% in each group also being treated with concurrent bevacizumab.

In the current study, they tested its safety and tolerability in combination with modified FOLFIRINOX (oxaliplatin 65 mg/m 2 , leucovorin 400 mg/m 2 , irinotecan 140 mg/m 2 , and fluorouracil 400 mg/m 2 bolus followed by 2400 mg/m 2 over 46 hours) in 20 adults with newly diagnosed metastatic pancreatic adenocarcinoma.

Median overall survival was 31.3 months for the 36 patients who proceeded to surgery after receiving four cycles of FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel), compared with 15.9 months for the 24 who were not offered surgery, report Salah-Eddin Al-Batran (Institute of Clinical Cancer Research, Frankfurt) and colleagues. --- As reported in the Journal of Clinical Oncology , among 225 cancer patients with opioid-induced constipation, a 14-day course of the peripherally acting μ-opioid receptor antagonist naldemedine – at a daily dose of 0.1, 0.2, or 0.4 mg – led to a significant improvement in the frequency of spontaneous bowel movements over placebo.